Karl Storz recalls flexible video cysto-urethroscopes with serial numbers from January 2018 due to failure to achieve six-log reduction in microorganisms after disinfection. Consumers should contact Karl Storz for details.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Karl Storz is recalling certain flexible video cysto-urethroscopes made since January 2018 because they may not reduce microorganisms to the expected level after disinfection. This could lead to infections if the devices are used without proper cleaning.
The devices may not reduce microorganisms to the required level after disinfection, which could lead to infections during medical procedures. This happens because the disinfection process does not achieve the expected six-log reduction in bacteria.
Medical professionals who use these devices for procedures like cystoscopy are most at risk. Patients using the devices for medical treatments may also be affected if the disinfection process fails.
Check for serial numbers manufactured since January 2018. The product codes include 11272VUE, 11272VUEK, or 11272VUE-R models with UDI codes 4048551431382 or 4048551444351.
Look for serial numbers manufactured since January 2018 on the device or packaging.
The devices may not achieve the expected six-log reduction in microorganisms after disinfection, which could lead to infections during medical procedures.
Contact Karl Storz directly for details on the recall and any necessary actions.
Yes, models 11272VUE, 11272VUEK, and 11272VUE-R with serial numbers from January 2018 are affected.
We’ve drafted a message you can send Karl Storz to request your refund or repair — edit it as you like.
Subject: Recall Z-1065-2022 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-1065-2022 from Karl Storz. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
